Prescription drug · NDA
Azmiro (testosterone cypionate) NDC 24338-056
Testosterone cypionate 200 mg/mL · Injection, Solution · Intramuscular · Azurity Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 24338-056-01 | 24338005601 | 1 VIAL in 1 CARTON (24338-056-01) / 1 mL in 1 VIALMarketed from Oct 4, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Azmiro
- Generic name (nonproprietary)
- testosterone cypionate
- Active ingredients
- Testosterone cypionate — 200 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 216318
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
- Identifiers
- Product ID 24338-056_5cf15fb2-1ba1-4295-9ddf-e98434ccd1c2SPL ID 5cf15fb2-1ba1-4295-9ddf-e98434ccd1c2SPL set ID 235b5625-570d-3fba-e063-6394a90aa2d1RxCUI 2047882, 2694309, 2694316, 2694320UNII M0XW1UBI14UPC 0324338055014
- Pharmacologic class
- Androgen
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N424338005601followed by a unit qualifier and the quantityPackage 24338-0056-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
AZMIRO is indicated for testosterone replacement therapy in males in conditions associated with a deficiency or absence of endogenous testosterone: • Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchiectomy, Klinefelter’s syndrome, or toxic damage from alcohol or heavy metals, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle stimulating hormone (FSH), luteinizing hormone (LH)) above the normal range [ see Dosage and Administration ( 2.2 ) ]. • Hypogonadotropic hypogonadism …
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 216318
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Azmirotestosterone cypionate | Testosterone cypionate 200 mg/mL | Injection, SolutionIntramuscular | Azurity Pharmaceuticals, Inc. | 24338-055 |